NCT07367347CompletedNot Applicable
The Effect of Increased BMI on Efficacy of Labor Analgesia: A Retrospective Cohort Study
Mariah Arif1 site in 1 country9,000 target enrollmentStarted: February 2, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9,000
- Locations
- 1
- Primary Endpoint
- Success rate of labor analgesia
Study Overview
Brief Summary
This study seeks to identify the most effective neuraxial technique for labor analgesia in Class III parturient
Detailed Description
This retrospective cohort study collected data on eligible participants from the electronic medical records.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age > or equal to 18 years
- •BMI ≥ 40 kg/m²
- •Gestational age ≥ 28 weeks
Exclusion Criteria
- •Age < 18 years
- •BMI < 40 kg/m²
- •History of venous thromboembolism or arterial disease (e.g., DVT, PE, angina, MI, or stroke)
- •Severe active lung, cardiovascular, renal, or liver disorders; autoimmune disease; or hemoglobinopathies
- •Hereditary or acquired thrombophilia (e.g., Factor V Leiden mutation or antithrombin deficiency)
- •In utero fetal demise (IUFD)
- •Failed operative vaginal delivery
- •Cesarean for the second twin or multiple pregnancies (triplets or higher)
- •IVF pregnancy
- •Intraoperative bleeding>1500mL
- •Emergency cesarean section (Category I)
- •Presence of large uterine fibroid ≥10 cm.
Arms & Interventions
Class III obese parturient
Class III obese parturient receiving neuraxial analgesia
Intervention: Neuraxial analgesia (Procedure)
Outcomes
Primary Outcomes
Success rate of labor analgesia
Time Frame: onset of neuraxial analgesia to completion of labor
The success rate of each technique will be determined by: Number of patients requiring a physician top-up bolus Block symmetry First-attempt success rate
Secondary Outcomes
- Maternal adverse events(onset of neuraxial analgesia to completion of labor)
- Fetal adverse events(at 1 and 5 minutes after birth)
Investigators
Mariah Arif
Resident Physician
Hamad General Hospital
Study Sites (1)
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